STERILE HYDROGEL— 510(k) K993119

Name: FDA 510(k) clearance K993119
Creator: U.S. Food and Drug Administration
Published: 1999-11-23

Substantially Equivalent

Dumex Medical Surgical Products, Ltd.

FDA 510(k) clearance K993119 for STERILE HYDROGEL, Substantially Equivalent on 1999-11-23. Applicant: Dumex Medical Surgical Products, Ltd.. Device class: Unclassified.

Clearance details

Applicant: Dumex Medical Surgical Products, Ltd.
Product code: Code MGQ
Device class: Unclassified
Advisory panel: Unknown
Date received: 1999-09-20
Decision date: 1999-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, Orntario, CA

Download summary PDF View on FDA.gov ↗

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K992732 — STERILE WATER & STERILE 0.9% SODIUM CHLORIDE2000-04-20
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K980779 — THALAFIX NATURAL SEA SALT DRESSING1998-06-26
K980861 — DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL1998-05-20
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Adverse events under product code MGQ

product code MGQ

Death: 16
Total: 16

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.